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A Double-Blinded Placebo-Controlled Randomized Trial with or without Memantine for the Prevention of Radiation-Induced Cognitive Dysfunction in Brain Metastatic Patients—CTRI/2022/01/039599: An Interim Analysis
CC BY 4.0 · Indian J Med Paediatr Oncol 2024; 45(S 01): S1-S16
DOI: DOI: 10.1055/s-0044-1788206
*Corresponding author: (e-mail: duttadeb07@gmail.com).
Abstract
Keywords
► brain metastases
► radiotherapy
► neuroprotective agents
► memantine
► SRS
► focal therapy
► WBRT
► HAWBRT
► randomized study
► placebo controlled
► Indian patient
Background: A randomized study to confirm the efficacy of memantine as a cognitive function protective agent for brain metastatic (BM) patients receiving whole brain radiation therapy (WBRT), hippocampal avoidance WBRT (HAWBRT), and stereotactic radiosurgery (SRS).
Materials and Methods: Adult patients (18–75 years, PS 0–2) with BM planned for WBRT, HAWBRT, and SRS were randomized to placebo or memantine (20 mg/day) for 6 months [target accrual 130, stratification-RT-type]. Addenbrooke’s Cognitive Examination (ACE) and MMSE and CTCAE performed at baseline, 16, and 24 weeks. Change in cognitive scores compared between arms.
Results: A total of 163 patients were screened, 89 accrued. In addition, 44 randomized to placebo (Arm A) versus 45 into memantine (Arm B) [mean age: 57.4]. In arms A and B, HA-WBRT, SRS, and WBRT patients accrued 7, 12; 25, 22; 12, 11. Four 6-month follow-ups done in 47 (Arm A: 25/Arm B: 22); 28 patients (14/14). ACE in arms A and B at baseline, 4 and 6 months were 75 ± 19.3 and 77.5 ± 14 (p-value: 0.48), 72.7 ± 19.8, 81 ± 13.4 (p-value: 0.09), 73 ± 23.9, 85.7 ± 12.1 (p-value: 0.08). ACE change at 4 and 6 months from baseline in A and B were −7.2 ± 9.8 and 4.5 ± 8.1 (p-value < 0 class="i" xss=removed>p-value < 0 class="i" xss=removed>p-value: 0.001), −11 ± 19.6, 9 ± 9.3 (p-value: 0.02), respectively.
Conclusion: In interim analysis, the memantine arm had statistically significant cognitive preservation in brain metastatic patients receiving SRS.
Publication History
Article published online:
08 July 2024
© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)
Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India
*Corresponding author: (e-mail: duttadeb07@gmail.com).
Abstract
Keywords
► brain metastases
► radiotherapy
► neuroprotective agents
► memantine
► SRS
► focal therapy
► WBRT
► HAWBRT
► randomized study
► placebo controlled
► Indian patient
Background: A randomized study to confirm the efficacy of memantine as a cognitive function protective agent for brain metastatic (BM) patients receiving whole brain radiation therapy (WBRT), hippocampal avoidance WBRT (HAWBRT), and stereotactic radiosurgery (SRS).
Materials and Methods: Adult patients (18–75 years, PS 0–2) with BM planned for WBRT, HAWBRT, and SRS were randomized to placebo or memantine (20 mg/day) for 6 months [target accrual 130, stratification-RT-type]. Addenbrooke’s Cognitive Examination (ACE) and MMSE and CTCAE performed at baseline, 16, and 24 weeks. Change in cognitive scores compared between arms.
Results: A total of 163 patients were screened, 89 accrued. In addition, 44 randomized to placebo (Arm A) versus 45 into memantine (Arm B) [mean age: 57.4]. In arms A and B, HA-WBRT, SRS, and WBRT patients accrued 7, 12; 25, 22; 12, 11. Four 6-month follow-ups done in 47 (Arm A: 25/Arm B: 22); 28 patients (14/14). ACE in arms A and B at baseline, 4 and 6 months were 75 ± 19.3 and 77.5 ± 14 (p-value: 0.48), 72.7 ± 19.8, 81 ± 13.4 (p-value: 0.09), 73 ± 23.9, 85.7 ± 12.1 (p-value: 0.08). ACE change at 4 and 6 months from baseline in A and B were −7.2 ± 9.8 and 4.5 ± 8.1 (p-value < 0 class="i" xss=removed>p-value < 0 class="i" xss=removed>p-value: 0.001), −11 ± 19.6, 9 ± 9.3 (p-value: 0.02), respectively.
Conclusion: In interim analysis, the memantine arm had statistically significant cognitive preservation in brain metastatic patients receiving SRS.
No conflict of interest has been declared by the author(s).
Publication History
Article published online:
08 July 2024
© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)
Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India